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FDA: Add arrhythmia risk warning on azithromycin

March 18, 2013 5:28am

The Philippine Food and Drug Administration has advised doctors and manufacturers of the dangers of the antibiotic azithromycin, amid recent findings it can potentially cause arrhythmia or irregular heartbeats.

In an advisory posted online early Sunday, the FDA said such a condition may be triggered by “drug interactions” and may be prevented by avoiding certain medicines in a patient’s regimen.

“Azithromycin is an antimicrobial medicine which is life-saving for serious bacterial infection. Due to Pharmacovigilance post-marketing surveillance from the US FDA, a significant adverse reaction was found and hence additional warning was mandatorily added to this specific product information,” it said.

For now, the FDA said it is sending “Dear Doctor” letters to advise physicians on this new finding. The letters remind doctors of “their responsibility to further advise patients needing this drug.”

It is also holding discussions with the concerned industry to “place additional new warnings in their product label.”